FDA official says agency cannot ensure safety of all medications sold in U.S.

Apr 26 2008

Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, on Thursday at a Senate hearing said that the number of medication ingredients manufactured abroad limits the ability of the agency to ensure the safety of all treatments sold in the U.S., CQ HealthBeat reports (Carey, CQ HealthBeat, 4/24).

At a Senate Education, Labor, Health and Pensions Committee hearing, Woodcock said that FDA "can't be the quality control unit of the world." She added, "We'll never have enough resources to do that" (Edney, CongressDaily, 4/25). Woodcock said, "The FDA of the last century is not constructed" to regulate the current amount of medications and foods manufactured abroad, adding, "Inspection resources have dropped while responsibilities have soared" (CQ HealthBeat, 4/25).

According to Woodcock, FDA seeks to establish a database of all companies that import medications and foods into the U.S. She also said that FDA requires additional funds to conduct more inspections, update information technology systems, improve laboratory science, and begin education and outreach efforts that target foreign regulators and companies (CongressDaily, 4/25). In addition, Woodcock said that pharmaceutical companies should take more responsibility for the safety of their products.

After the hearing, Woodcock said, "We're holding them accountable for their quality system, not being their quality system." She added, "Any legislative fixes that do not address quality by design will fail."

During the hearing, committee Chair Edward Kennedy (D-Mass.) said that FDA requires additional funds to conduct more inspections. He also said that pharmaceutical companies must improve the tests they use to detect contaminants and impurities in their products. "Even the most up-to-date manufacturing processes won't ensure safety if manufacturers can't guarantee the ingredients aren't contaminated," Kennedy said.

Committee ranking member Mike Enzi (R-Wyo.) said that additional inspections by FDA would not ensure the safety of medications and foods imported to the U.S. He said, "The reality of the global economy is that testing every food and drug product from outside the (United States) is not currently possible, nor will it ever be" (CQ HealthBeat, 4/25).